ACP-196 in Subjects with Chronic Lymphocytic Leukemia
Research type
Research Study
Full title
A Phase 1, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects with Chronic Lymphocytic Leukemia
IRAS ID
150175
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2014-000440-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
118717, IND Number
Duration of Study in the UK
2 years, 11 months, 20 days
Research summary
This study will evaluate the effects of an experimental drug called ACP-196. ACP-196 is a type of drug that blocks proteins inside cells that help cells live and grow. The specific protein blocked by the study drug is believed to help blood cancer cells live and grow. It is possible that the study drug may kill the cancer cells or stop them from growing.
This study will evaluate the effects of an experimental drug ACP-196 given by mouth to Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL.
Participation in the study can last for 60 or more cycles depending upon when participants started the study. This will include coming to the study centre approximately 32-38 times during the study (including this visit).
This trial will be monitored in accordance with the sponsor’s Pharmacovigilance
Committee procedures. Adverse events and SAEs will be reviewed internally on
an ongoing basis to identify safety concerns. Monthly conference calls with the
investigators will be conducted to discuss study progress, obtain investigator
feedback and exchange, and discuss "significant safety events" (ie, AEs leading
to dose reductions, related SAEs, and deaths). In addition, mandatory safety calls
will occur before enrollment of participants into the next cohort level.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0131
Date of REC Opinion
14 May 2014
REC opinion
Favourable Opinion